Translational Research & Pharmacology Core Program Director/Principal Investigator: Gerson, Stanton L. PROJECT SUMMARY (See instructions): The primary role of the Translation Research & Pharmacology Core is to facilitate the implementation of scientifically rigorous correlative study components for Case CCC clinical trials. The Core has four components - a central office and cellular and molecular biology lab; a clinical processing lab; a clinical pharmacology lab; and a cancer pharmacology (mass spectrometry) lab. Core staff is composed of an experienced team dedicated to facilitating all aspects of the correlative study components of Case CCC clinical trials, guaranteeing consistent quality control. The TRC also includes an effort initially supported with UOl funds to perform in vitro testing of new drugs and combination therapies. The central, clinical processing and pharmacology labs are administered by the Case CCC, while the clinical pharmacology lab is managed through Cleveland Clinic, but is part of this Core operation. The service is to support correlative studies within Case CCC clinical trials. Support from the CCSG stabilizes the Core financially and provides clinical investigators formal ability to obtain clinical correlates. Formal access to Core services is extended to Case CCC members across the consortium sites. Services provided by the Core include: 1) consultation or full service writing of methods sections and budgets for CTEP letters of intent, protocols, and grants; 2) sample informatics and correlate data; 3) data analysis; 4) sample handling (receiving, storage, distribution); 5) sample processing (dispensing whole blood aliquots, routine blood processing, DNA, RNA and protein extraction, flow or laser scanning cytometry staining); 6) lab analysis (western blots, ELISAs, MSD multiplex analysis, PARP activity and Poly(ADP)-ribose assay, comet assays); 7) single or multiple agent cytotoxicity multiple agent analysis), 8) pharmacokinetic assay development, and 9) pharmacokinetic assay performance. The Core handles specimens from ~100 trials per year, members from all of the Case CCC Scientific Research Programs utilize the Core, and the user base is >95% Case CCC membership. The Core played a key role in numerous projects including: the first-in-human trial of the base excision inhibitor methoxyamine used in combination with temozolomide (Cancer Pharmacology Lab) and the design and operation ofthe Gl SPORE Biospecimen Core.